510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K211649Substantially Equivalent

PCEA Syringe Set

Baxter Healthcare Corporation, Round Lake IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K211649 is the FDA 510(k) clearance record for PCEA Syringe Set, a class II device, cleared for Baxter Healthcare Corporation on under FDA product code PWH (Administrations Sets With Neuraxial Connectors). FDA's definition for product code PWH reads: "The connector for neuraxial applications is intended to facilitate ANSI/AAMI/ISO 80369-6:2016 compliant neuraxial specific connections". FDA records list 570 510(k) clearances for Baxter Healthcare Corporation, from to . As of , FDA records show no recalls naming K211649.

Clearance record

Decision date
Received
(179 days to decision)
Product code
PWH Administrations Sets With Neuraxial Connectors
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Baxter Healthcare Corporation 25212 W. Illinois Rte. 120, Round Lake IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PWH

Trailing 12 months

FDA records hold no clearances under product code PWH in the trailing twelve months.

FDA records show no clearances under product code PWH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PWH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260